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The application of Shuanghuanglian combined with early enteral nutrition in the nursing of elderly patients undergoing pancreaticoduodenectomy: a randomized controlled trial

The application of Shuanghuanglian combined with early enteral nutrition in the nursing of elderly patients undergoing pancreaticoduodenectomy: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001685
Enrollment
Unknown
Registered
2025-09-09
Start date
2023-11-25
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreaticoduodenectomy in elderly patients

Interventions

Observation Group:The observation group began to receive SHL-OL (Heilongjiang Linbao Pharmaceutical Co., Ltd., batch number: Z23020924
specification: 10 milliliters per bottle) 30ml via nasogastric tube 12 hours after surgery (heated to 37°C, with the tube clamped for 1 hour after administration), while the same EEN regimen was used.
Control Group:On the basis of routine postoperative treatment, 500ml of 5% glucose and sodium chloride solution was administered via nasogastric tube at 12 hours after surgery, and nutritional solutio

Sponsors

Jining Medical University Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: Age 60-80 years; preoperative diagnosis is clear; malnutrition exists and requires enteral nutrition support; patient voluntarily accepts the treatment plan of this study and signs an informed consent form.

Exclusion criteria

Exclusion criteria: Cardiopulmonary renal function, coagulation indicators are abnormal, gastrointestinal function is intolerant; allergic to the components of Shuanghuanglian oral liquid or enteral / parenteral nutrition solution; voluntarily refuse to accept the treatment plan of this study; meet the inclusion criteria but did not implement enteral nutrition as planned after inclusion.During the treatment process, patients voluntarily withdraw or encounter unexpected circumstances that prevent them from continuing treatment; during the trial, serious adverse reactions or special physiological changes occur, making it unsuitable to continue the trial, which are recorded as adverse events; patient information is incomplete, affecting the judgment of effectiveness and safety.

Design outcomes

Primary

MeasureTime frame
Stress Indicators 72 hours after Surgery (Cortisol [COR] Adrenocorticotropic Hormone [ACTH] Epinephrine [EPI]);Time of First Defecation;Inflammatory Indicators 72 hours after Surgery (C-reactive Protein [CRP] Interleukin-6 [IL-6]);

Secondary

MeasureTime frame
Quality of Life;Patient Comfort and Satisfaction;Occurrence of Adverse Events;

Countries

China

Contacts

Public Contactzhangpeilu

Jining Medical University Affiliated Hospital

1107170501@qq.com+8615605479332

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026